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United States · US · US:25021-333_b5132d2b-418f-461f-9270-de5c89e2a514
Nicardipine Hydrochloride
Orange BookUNIISPLATC C08CA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeC08CA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11250213331010 VIAL in 1 CARTON (25021-333-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
K5BC5011K3
NICARDIPINE HYDROCHLORIDE
RxCUI 235230
Orange Book
A219608
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K5BC5011K3",
"rxcui": "235230",
"inchikey": "AIKVCUNQWYTVTO-UHFFFAOYSA-N",
"display_name": "NICARDIPINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"b0e2bed3-f928-43ab-a05c-275bedc9856f": {
"match": "brand_token",
"title": "NICARDIPINE HYDROCHLORIDE INJECTION [LIFESTAR PHARMA LLC]",
"spl_version": "3",
"published_date": "2026-04-27"
}
},
"productid": "25021-333_b5132d2b-418f-461f-9270-de5c89e2a514",
"productndc": "25021-333",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "219608",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "25MG/10ML (2.5MG/ML)",
"product_no": "001",
"approval_date": "Oct 28, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NICARDIPINE HYDROCHLORIDE",
"proprietary_name": "Nicardipine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA219608",
"marketing_category": "ANDA",
"nonproprietary_name": "Nicardipine Hydrochloride",
"start_marketing_date": "20260101",
"active_numerator_strength": "2.5"
}Related drugs
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